Actively Recruiting
Remote Anxiety Management for ICS-resistant Asthma Study
Led by First Affiliated Hospital of Ningbo University · Updated on 2026-03-31
216
Participants Needed
11
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study, the Remote Anxiety Management for ICS-resistant Asthma Study (RAMICS), explores strategies to improve medication adherence and anxiety management in asthma patients who are resistant to using inhaled corticosteroids (ICS) due to anxiety. Asthma is a chronic respiratory disease affecting millions worldwide, and ICS therapy is essential for controlling symptoms and preventing severe exacerbations. However, many patients struggle with adherence, especially those with anxiety about ICS side effects. RAMICS is a multicenter, open-label, randomized controlled trial designed to evaluate the effectiveness of personalized telephone-based interventions, including medication education, progressive muscle relaxation (PMR), motivational interviewing (MI), and lung rehabilitation guidance. The study will enroll 216 adult asthma patients with poor ICS adherence and clinically significant anxiety. Participants will be randomized into two groups: the intervention group, receiving weekly telephone sessions, and the control group, receiving standard follow-up calls. The study aims to assess improvements in ICS adherence, reductions in anxiety and depression, better asthma symptom control, and enhanced quality of life. Outcomes will be evaluated immediately after the 8-week intervention and during a 3-month follow-up. By addressing both psychological and medication adherence challenges, this research aims to provide practical solutions for improving asthma management.
CONDITIONS
Official Title
Remote Anxiety Management for ICS-resistant Asthma Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
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Age Requirement:
Participants must be aged 18 to 80 years, ensuring they are adults capable of making decisions and responding effectively to interventions.
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Diagnosed Asthma:
- Diagnosis must meet the criteria of the Global Initiative for Asthma (GINA) or the American Academy of Asthma guidelines, with at least one confirmed diagnosis by a specialist in the past six months.
- Asthma severity must range from mild to moderate persistent, in the chronic management phase, excluding patients in acute exacerbation phases for clearer evaluation of adherence and intervention effects.
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ICS Treatment History:
- Participants must have been on inhaled corticosteroid (ICS) therapy for at least six months, ensuring sufficient treatment history for adherence and effect evaluation.
- No major changes to asthma control medication regimen in the past six months, ensuring adherence and intervention outcomes are not confounded by treatment changes.
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Poor Medication Adherence:
Identified using the Medication Adherence Report Scale (MARS-10), with an average score <4.5, indicating suboptimal adherence.
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Presence of Anxiety Symptoms:
- Confirmed through the Hamilton Anxiety Rating Scale (HAMA), with a score ≥14, indicating clinically significant anxiety.
- Anxiety symptoms must be related to asthma treatment, particularly concerns about ICS side effects or long-term use, ensuring the psychological intervention targets relevant issues.
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Ability to Communicate by Phone:
Participants must have stable access to a phone and be willing to engage in telephone-based psychological interventions.
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Stable Health Condition:
Asthma status must be stable, with no acute exacerbations or significant changes in the past month.
You will not qualify if you...
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Severe Psychiatric or Cognitive Disorders:
- Diagnosis of major psychiatric disorders, such as major depressive disorder, bipolar disorder, schizophrenia, or other severe mental illnesses within the past six months, based on DSM-5 criteria.
- Presence of cognitive impairments or neurological conditions, such as dementia or post-stroke complications, that may affect comprehension or adherence to the intervention.
- Current psychiatric treatment involving antipsychotics, antidepressants, or sedatives that could interfere with the intervention's outcomes.
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Substance Abuse or Dependence:
History of alcohol or drug abuse within the past six months, including but not limited to opioids, benzodiazepines, or illicit substances.
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Severe Comorbidities:
- Uncontrolled respiratory or cardiovascular conditions, such as chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung disease, heart failure, or uncontrolled hypertension, that could significantly impact asthma control and overall health.
- Chronic diseases requiring long-term systemic corticosteroid therapy, such as rheumatic or autoimmune diseases, that may interfere with ICS treatment and study outcomes.
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Pregnancy or Lactation:
Pregnant or breastfeeding women are excluded due to the unclear risks of ICS treatment and anxiety management interventions in these populations.
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Allergic Bronchopulmonary Aspergillosis (ABPA) or Related Conditions:
Diagnosed ABPA or other respiratory diseases with mechanisms distinct from asthma, which could confound the assessment of ICS treatment effects.
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Participation in Other Interventional Clinical Trials:
Participation in another interventional clinical trial within the past three months, particularly those involving respiratory diseases or medication adherence management, to avoid confounding effects on outcomes.
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Incompatibility with Telephone-Based Interventions:
Inability to reliably receive or engage in telephone-based psychological interventions due to hearing impairments, communication barriers, or other reasons.
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Adverse Reactions to Psychological Interventions:
Documented refusal of or adverse reactions to psychological interventions, such as phone-based relaxation or motivational interviewing, that could affect the feasibility and effectiveness of the study.
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History of Major Surgery or Hospitalization:
History of major surgery or hospitalization (unrelated to asthma) within the past six months that might impact current health status and introduce bias into the study outcomes.
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Second Affiliated Hospital of Harbin Medical University
Harbin, China
Actively Recruiting
2
Anhui Chest Hospital
Hefei, China
Actively Recruiting
3
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Actively Recruiting
4
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
Actively Recruiting
5
Jingzhou Central Hospital
Jingzhou, China
Actively Recruiting
6
Haishu District People's Hospital
Ningbo, China
Not Yet Recruiting
7
Ningbo Medical Center Lihuili Hospital
Ningbo, China
Actively Recruiting
8
Qianhu Hospital
Ningbo, China
Actively Recruiting
9
The First Affiliated Hospital of Ningbo University
Ningbo, China
Actively Recruiting
10
Ninghai County First Hospital
Ninghai, China
Actively Recruiting
11
Taizhou Central Hospital
Taizhou, China
Not Yet Recruiting
Research Team
C
Chao Cao
CONTACT
S
Shiyi He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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